Cellulite ReductionPhase 4NCT01026441
Clinical Study to Evaluate the Safety and Efficacy of the Vela100
A Phase 4 study testing Vela100 (Aesthetic) in people with Cellulite Reduction and Circumference Reduction, run by Syneron Medical at 2 sites in United States.
Trial summary
This study is intended to test the safety of the Vela100 device when used for treatment for cellulite and circumference temporary reduction. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cellulite Reduction, Circumference Reduction
- What is being tested?
- Vela100 (Aesthetic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent agreement signed by the subject.
- Healthy males or females older than 21 years of age but not older than 60 years of age.
- Fitzpatrick Skin Type I to VI
- Having at least two areas (abdomen, buttocks and thighs) suitable for treatment.
- BMI score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
- For female of child bearing potential - using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Who cannot join
- Pregnant or planning to become pregnant, having given birth (vaginal birth or Caesarean surgery) less than 9 months ago, and/or breastfeeding.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
- Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
- Having undergone a liposuction surgery or any contouring treatment in the areas intended for treatment within 9 months of treatment or during the study.
- For post-liposuction areas, the procedure should also not have been performed more than 2 years prior to this study.
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- Having undergone any other surgery in the treated areas within 9 months of treatment or during the study.
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- Suffering from hormonal imbalance which may affect weight or cellulite, as per the Investigator's discretion.
- History of significant lymphatic drainage problems. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- History of keloid scarring or of abnormal wound healing.
- History of being especially prone to bruising.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- Use of isotretinoin (Accutane®) within 6 months of treatment or during the study.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) during, as well as two weeks before and after, the treatment course.
- Use of anti-cellulite creams within a month of treatment or during the course of the study.
- If any allergy that is related to the lotion used in this study appears, subjects may be excluded from the study.
- Recently tanned in areas to be treated and/or unable or unlikely to refrain from tanning during the study.
- Significant change in diet or exercise regimen within a month of enrollment or during this study and/or weight loss or gain of 10 lbs (4.5 kgs) within 2 months of enrollment or during this study.
- Participation in a study of another device or drug within 1 month prior to enrollment or during this study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kavali Plastic Surgery and Skin Renewal Center
Atlanta, Georgia, 30342
Orange Coast Women's Medical Group
Laguna Hills, California, 92653
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of the Vela100/eShape Uno Device for Cellulite and Circumference Reduction
This study is intended to test the safety of the Vela100 device when used for treatment for cellulite and circumference temporary reduction.
- Conditions
- Cellulite Reduction, Circumference Reduction
- Being tested
- Vela100 (Aesthetic)
- Keywords
- Aesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vela100 (Aesthetic)Device
6 treatments once a week
| Study group | Role | What they receive |
|---|---|---|
| Treatment for cellulite and circumference reduction | Other | All subjects will be treated with the device Receives: Device: Vela100 (Aesthetic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: End of treatment, at 1 month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Product was not developed and study was cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cellulite ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026441
- Sponsor's protocol ID
- Vela100
- Status last verified
- May 2011
- First submitted
- 3 Dec 2009
- Last updated
- 5 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of the Vela100/eShape Uno Device for Cellulite and Circumference Reduction
- ClinicalTrials.gov ID
- NCT01026441
- Acronym / sponsor ID
- Vela100
- Conditions
- Cellulite Reduction, Circumference Reduction
- Keywords
- Aesthetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product was not developed and study was cancelled
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to test the safety of the Vela100 device when used for treatment for cellulite and circumference temporary reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment for cellulite and circumference reduction | Other | Device: Vela100 (Aesthetic)All subjects will be treated with the device |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Informed consent agreement signed by the subject.
- Healthy males or females older than 21 years of age but not older than 60 years of age.
- Fitzpatrick Skin Type I to VI
- Having at least two areas (abdomen, buttocks and thighs) suitable for treatment.
- BMI score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
Key exclusion criteria (24 listed)
- Pregnant or planning to become pregnant, having given birth (vaginal birth or Caesarean surgery) less than 9 months ago, and/or breastfeeding.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
- Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
- Having undergone a liposuction surgery or any contouring treatment in the areas intended for treatment within 9 months of treatment or during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vela100 (Aesthetic)6 treatments once a week | Device | Treatment for cellulite and circumference reduction |
Primary outcome
Adverse Events
Time frame: End of treatment, at 1 month FU
Results and safety
The study was stopped early (reason given: Product was not developed and study was cancelled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vela100 (Aesthetic) in people with Cellulite Reduction and Circumference Reduction, run by Syneron Medical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Product was not developed and study was cancelled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: End of treatment, at 1 month FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.